text4FATHER R21: Social Media - Efficacy Trial

NCT06289101 | Recruiting

• 2 other identifiers: IRB00422008R21HD112617
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being.

Conditions

Fathers; Mobile Health; Nuclear Family

Keywords

Fatherhood

Outcome Measures

Primary Outcomes (3)

• Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC)

  Self-report measure with higher score indicating greater confidence in overall parenting skills. This measure is scaled with range from 1 (low) to 6 (high). Mean range 1-6.

  Baseline and 7 months

• Karitane Parenting Confidence Scale (KPCS)

  Self-report measure with higher score indicating greater confidence in infant care behaviors. This measure is scaled with range from 0 (no, hardly ever) to 3 (yes, most times). Mean range 0-3.

  Baseline and 7 months

• Father Engagement Scale (FES)

  Self-report measure with higher score indicating greater degree of father engagement in infant care activities. This measure is scaled with range from 0 (never) to 4 (every day or almost every day). Mean range 0-4.

  Baseline and 7 months

Study Arms (2)

text4FATHER

EXPERIMENTAL

Receipt of twice-weekly texts that include resource links and instructions to support behavior change (e.g., videos, infographics) and start mid-pregnancy and continuing through 2 months of baby's age.

Behavioral: text4FATHER

Usual care

NO INTERVENTION

Usual care that is consistent with typical maternity care in involving fathers-to-be.

Interventions

text4FATHER BEHAVIORAL

Receipt of twice-weekly texts that include resource links and instructions to support behavior change (e.g., videos, infographics) and start mid-pregnancy and continuing through 2 months of age.

text4FATHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years
• Live in the U.S.
• Speak English
• Mother gestational age at enrollment less than 25 weeks
• First-time father-to-be
• Willing/able to receive texts.

You may not qualify if:

• Individuals who are minors
• Do not speak English
• Unable to provide informed consent
• Not a first-time father
• Not willing/unable to receive texts
• In the past 12 months, any safety concern reported between father-to-be and the mother-to-be, including report of any physical, emotional, sexual harm, threatening behaviors, police involvement, restraining or protective order

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (4)

• Marcell AV, Johnson SB, Nelson T, Labrique AB, Eck KV, Skelton S, Aqil A, Gibson D. Protocol for the Feasibility, Acceptability, and Preliminary Efficacy Trial of text4FATHER for Improving Underserved Fathers' Involvement in Infant Care. J Health Care Poor Underserved. 2021;32(3):1110-1135. doi: 10.1353/hpu.2021.0117.

  PMID: 34421016 BACKGROUND

• Allport BS, Johnson S, Aqil A, Labrique AB, Nelson T, Kc A, Carabas Y, Marcell AV. Promoting Father Involvement for Child and Family Health. Acad Pediatr. 2018 Sep-Oct;18(7):746-753. doi: 10.1016/j.acap.2018.03.011. Epub 2018 Apr 10.

  PMID: 29653255 BACKGROUND

• Allport-Altillo BS, Aqil AR, Nelson T, Johnson SB, Labrique AB, Carabas Y, Marcell AV. Parents' Perspectives on Supporting Father Involvement in African American Families During Pregnancy and Early Infancy. J Natl Med Assoc. 2020 Aug;112(4):344-361. doi: 10.1016/j.jnma.2020.04.002. Epub 2020 May 11.

  PMID: 32409095 BACKGROUND

• Aqil A, Allport BS, Johnson SB, Nelson T, Labrique AB, Marcell AV. Content to share with expectant fathers: Views of professionals focused on father involvement. Midwifery. 2019 Mar;70:119-126. doi: 10.1016/j.midw.2018.12.018. Epub 2018 Dec 24.

  PMID: 30611921 BACKGROUND

Study Officials

• Arik Marcell, MD, MPH

  Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arik V Marcell, MD, MPH

CONTACT

4432878946; amarcell@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups will be enrolled and randomized to receipt or not receipt of the intervention.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 1, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

US (1)